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. 2020 Sep 8;6(2):420–432. doi: 10.1016/j.bioactmat.2020.08.021

Table 8.

Fundamental elements in the design of animal study for intraperitoneal hernia mesh [93].

Fundamental elements Relevant content in the guidance
Animal species Large mature animals (such as minipigs and beagles)
Selection of control The most similar marketed intraperitoneal mesh in terms of material and structural design in China.
Selection of evaluation criteria Adhesion strength, adhesion area, acceptable rate of adhesion, condition of newly-grown peritoneum, adverse reactions, and histological reactions.
Selection of observation time For non-absorbable adhesion reducing materials, at least observe for 28 days after implantation. For absorbable adhesion reducing materials, the observation period should be determined according to the expected time of complete degradation of the product.